Pain-care industry in need of prescription to reduce deaths

People in pain have a right to have their pain treated adequately, but in Florida the spiraling use of narcotic painkillers has put patients in peril and led to hundreds of deaths.

Pain management experts, family doctors, the state attorney general and health officials say the system is in need of immediate repair.

Prescription narcotics, a Sun-Sentinel investigation found, have killed almost 400 people in a seven-county area of southeast Florida in the last two years.

The number of deaths attributed to it makes it a very bad problem, said Dr. Gary Winchester, chairman of the Florida Board of Medicines Quality Assurance Committee.

But if there are that many dead, just think about how many other things could be going on because [of these drugs]  people getting into accidents, having family problems, losing their jobs.

While most doctors prescribe the drugs properly and most patients take them the way they were intended, the newspapers four-month investigation found a burgeoning pain management industry ripe for abuse, with little oversight and inadequate safeguards:

Some doctors have had multiple overdose deaths among their pain patients; others are freely prescribing narcotics outside Florida Board of Medicine guidelines. But the board has no tracking mechanism that could uncover such trends.
The few doctors who have been arrested in connection with overprescribing painkillers were found by the states Medicaid fraud unit, which was looking at the heaviest prescribers of OxyContin, a powerful narcotic painkiller.

Neither law enforcement agencies investigating overdose deaths nor the states medical examiners who perform the autopsies track doctors with multiple deaths among their patients. Neither routinely reports the names of doctors whose patients have died to the state agencies with the power to discipline doctors.

Patients who go from doctor to doctor to get multiple prescriptions of narcotics often end up dead, and there is no comprehensive system in place to catch them while theyre alive.
Winchesters committee came up with recommendations to solve these problems late last year. The Board of Medicine endorsed them and sent them to the Legislature for action, but only a few made it into bills, and only one passed.
I thought we had a pretty comprehensive package, and there was a lot of backing from the attorney general and the governors drug czar, but I guess there are no guarantees, Winchester said. Thats the way politics works.
The 393 deaths reviewed by the Sun-Sentinel came in the wake of a national push for doctors to adequately treat their patients pain  which sometimes was undertreated because doctors feared they would addict the patient or draw scrutiny from law enforcement or the medical board.
But the new policies also have prompted the growth of a pain management industry that is largely unregulated.
The number of deaths is deplorable, Attorney General Bob Butterworth said. People need to know what the dangers are, especially with OxyContin. Too many people are getting that drug who dont need it.
The drug, a synthetic morphine in time-release form, was found at the scene of at least 64 overdose deaths, and is suspected in others, but toxicology tests after death cannot distinguish the drug from other forms of oxycodone.
Butterworths office is investigating doctors whose patients are excessively billing Medicaid for OxyContin, as well as the marketing practices of the drugs maker, Purdue Pharma, based in Stamford, Conn.
But the state needs to strengthen its oversight of doctors in order to target those who are prescribing narcotics recklessly or mainly for financial gain, Butterworth and others said.
More and more its becoming a law enforcement problem and a social tragedy, said Mark Schlein, director of the Attorney Generals Medicaid Fraud Division, which has been conducting an investigation of OxyContin abuse statewide. Its very similar to the crack cocaine surge about 10 years ago. It exploded on a nation that wasnt prepared.
He said his office is looking for doctors who are dispensing or prescribing OxyContin mainly to inflate their bank accounts. As a starting point, they are reviewing data on which doctors are the top prescribers.
Many people are turning these drugs into a source of large amounts of money. We have doctors knowingly writing [prescriptions] inappropriately, and the result is death, he said.
The inquiry has resulted in three high-profile arrests of top OxyContin providers, and one conviction so far.
First-degree murder case
The case of Dr. Denis Deonarine, of Jupiter, the first doctor in the nation to be charged with first-degree murder in the death of a patient from OxyContin, came about as part of the Medicaid fraud investigation. Deonarine was writing a high volume of prescriptions for OxyContin, according to investigators.
Undercover agents who visited his medical office posing as patients had little trouble getting narcotics prescriptions, according to investigative documents. They also discovered that at least one of Deonarines patients had died.
Michael Labzda, 21, of Jupiter, died Feb. 8, 2001, from OxyContin and Xanax prescribed by the doctor only two days earlier, according to the medical examiners report. Prosecutors alleged the death occurred while Deonarine was trafficking in prescription narcotics. He has pleaded not guilty and is awaiting trial.
Dr. James Graves, 55, from the Panhandle town of Pace, also caught the attention of state investigators because he was the states No. 1 prescriber of OxyContin. His clients sometimes got into fistfights in the parking lot, and area pharmacists became outraged at the potentially lethal mix of drugs he routinely prescribed  the Graves cocktail, according to prosecutors in the case. Four of his patients died.
Graves was convicted of racketeering and four counts of manslaughter on Feb. 19 and sentenced in March to 63 years in prison.
The third doctor arrested is Asuncion Luyao, of Port St. Lucie, who has been charged with drug trafficking. An investigation into the deaths of a dozen of her patients is continuing.
The Legislature in its regular session that ended March 22 passed a law that makes it a third-degree felony for a doctor to prescribe narcotics solely for financial gain, to write a prescription to a fictitious person, or to prescribe or dispense more of the drug than medically necessary.
A doctor found guilty under the provisions could be fined $2,000 or sentenced to five years in prison.
But the Sun-Sentinel found that in hundreds of overdose deaths, police agencies called to the scene of an apparent overdose death give little attention to who prescribed the drugs because the drugs were legal and the patient had a prescription.
They do not routinely record the names of the doctors listed on prescription bottles in their reports.
Going after the doctor is totally new territory, said Dr. Lisa Flannagan, the Palm Beach County chief medical examiner. [Investigators] dont usually pursue them. This is all new, now that its prescription drugs rather than illegal drugs such as heroin or cocaine.
Medical examiners investigators in some counties, including Palm Beach, are diligent about recording information about the prescription drugs found at the scene, including the name of the prescribing doctor, but in other jurisdictions such information is sketchy to haphazard.
When the doctors names are recorded, they stay with the individual case file. If a pattern of deaths is occurring, it may not be noticed.
With all the information about people dying from [prescription drugs], youd think they would try to start linking these cases up, Butterworth said.
One of the recommendations made by the medical board committee was that state law be changed to require medical examiners to report all overdose deaths to the Florida Department of Health within 15 days. The board suggested the reports be similar to those hospitals must make to the state when a patient is injured by a medical mistake, which can include the names of medical practitioners involved.
The bill being considered in the special session of the Legislature, however, requires only that the state Medical Examiners Commission report prescription drug overdose deaths quarterly to the Florida Department of Health, as such information has been reported to the commission by the medical examiners within the state.
Medical examiners already are required to report the deaths and the drugs responsible, but not the names of prescribing doctors. Nothing in the proposed legislation would change that.
Detectives in Broward and Palm Beach counties say that even with growing awareness about prescription drug deaths, it is very difficult to make a criminal case against a doctor who may be recklessly prescribing.
Our State Attorneys Office wont prosecute unless you have somebody who can say they saw [the deceased] receive the drug, ingest the drug, and that it was the only drug he took, said Detective Sgt. William Springer, of the Palm Beach County Sheriffs Office.
Are we looking at who prescribed the drugs to them? No, he said. We wait for the toxicology report to come back, but as far as trying to determine where they got the drugs, we dont pursue that.
Broward Sheriffs Detective Lisa McElhaney, who works on prescription drug cases, said there is often a question whether the doctors actions are criminal or just malpractice.
When family members ask her to investigate a doctor for overprescribing narcotics for a relative, there is little she can do, McElhaney said.
The No. 1 question is: How are these doctors allowed to do this? My son or brother is just eating these pills.
But the doctor is licensed to do whatever he wants unless I can show criminal activity. And the kid isnt going to say hes doing it illegally, because thats cutting off his source, she said.
A computer analysis of information gathered by the Sun-Sentinel from medical examiner and police reports found 200 doctors had at least one patient die from a prescription drug overdose in the past two years. One had at least 14 patients die; nine had three to five deaths, and 39 had at least two.
The numbers of deaths alone do not mean doctors who prescribed the drugs are guilty of crimes, or even of practicing outside the bounds of good medicine.
Collecting such information could provide a red flag, however, for investigators charged with determining whether criminal prosecution or disciplinary action by the Board of Medicine is appropriate.
There is nothing in the proposed legislation that calls for gathering such information.
The bill does require that if a law enforcement agency arrests or indicts a doctor in connection with prescribing violations that the Florida Department of Health be notified so that it can consider whether to suspend the doctors license.
Patient responsibility
Patients who doctor-shop  go from doctor to doctor  to get drugs they can abuse or sell are at a high risk for death, said Dr. Michael Ashburn, immediate past president of the American Pain Society.
Even the best pain management doctors can lose a patient to an overdose, Ashburn said, because patients dont always follow the rules, even when they have signed an agreement saying they will.
Pain patients with a previous history of drug abuse pose a special problem, he said.
They are extremely difficult to take care of. Theyre extremely challenging, require a lot of energy and attention from their doctors, and even then, they do have relapses, Ashburn said.
The Sun-Sentinel found that 84 people who died from narcotic overdoses had visited several doctors to get their drugs, and 59 of them had used more than one pharmacy to help prevent detection.
Floridas Legislature is considering creating an electronic monitoring system that would track narcotics prescriptions to prevent patients from doctor-shopping to get multiple prescriptions.
Ashburn said he and other doctors in his pain practice at the University of Utah, Salt Lake City, have access to such a database.
Any physician can obtain a report on all of the opioids that have been prescribed to a patient. We fax a request to the state, and state faxes us an answer. If we find anybody [in our practice] is getting drugs from other doctors, we wont take care of them anymore.
Ashburn said all of his patients also know they are subject to random urine drug screens. People who fail the test also have to leave, he said.
Setting standards
Ashburn said if all doctors strictly followed the national guidelines for the use of controlled drugs in treating pain, the death toll might be reduced.
[Doctors] who focus on getting cash up front for opioid prescriptions are obviously not following the guidelines, Ashburn said. A review of any of those [overdose death] cases, theoretically, would show that.
The Florida Board of Medicine in 1999 issued pain management guidelines based on the national guidelines issued in 1997 by the American Academy of Pain Management and the American Pain Society.
The guidelines say doctors should:

Take a complete medical history and physical examination, documented in the medical record, including whether there is a history of substance abuse.

Write a treatment plan that will assess the effectiveness of the treatment, the need for further diagnostic tests, or further treatment such as a rehabilitation program.

Discuss the risks and benefits of the use of narcotics, and explain to the patient that he should receive prescriptions from only one physician and one pharmacy.

Use a written agreement signed by any patient considered to be at high risk for abusing the medication, spelling out that the doctor can require a urine screen at any time to check for drug abuse.

Re-evaluate the patient at reasonable intervals.

Keep accurate and complete medical records that document all of the above.

Be willing to refer the patient to another doctor if necessary for additional evaluation and treatment.

Comply with all state and federal laws governing the prescribing of controlled drugs.
Late last year the Board of Medicine recommended that these guidelines become the standard of care that must be followed by all Florida physicians who prescribe narcotic painkillers.
Theyre supposed to be followed, and you can be disciplined for not following them, said Dr. Rafael Miguel, a member of the medical board and professor at the University of South Florida medical school in Tampa.
The board will consider making the guidelines into standards when it meets in June. Doctors violating the standards could face discipline by the board.
Other key proposals for fixing the industry require action by the Legislature, but some did not make it into proposed legislation because of opposition from various groups including the Florida Medical Association, said Sen. Locke Burt, R-Ormond Beach, who sponsored the bills in the Florida Senate.
One recommendation would have required the use of tamper-proof prescription pads to prevent patients from forging prescriptions.
Another would have halted the practice of doctors dispensing narcotics directly from their offices, bypassing the pharmacy.
Medical Board Chairman Dr. Zachariah Zachariah said doctors who dispense these drugs from their offices face too much temptation to overprescribe them to boost their incomes.
Burt said he pushed for changes in the law because diversion of prescription drugs accounts for at least 30 percent of the states drug abuse problem.
Addicts know prescription drugs are quality-controlled, and its not a crime to possess them, Burt said.
Nancy McVicar can be reached at nmcvicar@sun-sentinel.com or 954-356-4593. Fred Schulte can be reached at fschulte@sun-sentinel.com or 954-356-4591.